Combination ultrasonic and electrosurgical instrument with a production clamp force based ultrasonic seal process and related methods

ABSTRACT

An ultrasonic surgical instrument and method of sealing a tissue based on a production clamp force includes determining an ultrasonic seal process with the controller based on the production clamp force between an upper jaw and a lower jaw of an end effector and activating the ultrasonic energy or RF energy according to the determined ultrasonic seal process. The ultrasonic surgical instrument further includes an end effector having an ultrasonic blade, a jaw, an RF electrode, and a controller. The jaw is movably positioned relative to the ultrasonic blade and configured to move between an open position and a closed position and clamp together with a production clamp force in the closed position. The controller operatively connects to the ultrasonic blade and the RF electrode and includes the ultrasonic seal process based on the production clamp force stored thereon for driving the ultrasonic blade or the RF electrode.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Pat. App. No. 62/509,336, entitled “Control Algorithm for Surgical Instrument with Ultrasonic and Electrosurgical Modalities,” filed May 22, 2017, the disclosure of which is incorporated by reference herein.

BACKGROUND

Ultrasonic surgical instruments utilize ultrasonic energy for both precise cutting and controlled coagulation. Ultrasonic energy cuts and coagulates by vibrating a blade in contact with tissue. Vibrating at frequencies of approximately 55.5 kilohertz (kHz), for example, the ultrasonic blade denatures protein in the tissue to form a sticky coagulum. Pressure exerted on the tissue with the blade surface collapses blood vessels and allows the coagulum to form a hemostatic seal. The precision of cutting and coagulation may be controlled by the surgeon's technique and adjusting the power level, blade edge, tissue traction, and blade pressure, for example.

Examples of ultrasonic surgical devices include the HARMONIC ACE® Ultrasonic Shears, the HARMONIC WAVE® Ultrasonic Shears, the HARMONIC FOCUS® Ultrasonic Shears, and the HARMONIC SYNERGY® Ultrasonic Blades, all by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio. Further examples of such devices and related concepts are disclosed in U.S. Pat. No. 5,322,055, entitled “Clamp Coagulator/Cutting System for Ultrasonic Surgical Instruments,” issued Jun. 21, 1994, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 5,873,873, entitled “Ultrasonic Clamp Coagulator Apparatus Having Improved Clamp Mechanism,” issued Feb. 23, 1999, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 5,980,510, entitled “Ultrasonic Clamp Coagulator Apparatus Having Improved Clamp Arm Pivot Mount,” issued Nov. 9, 1999, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 6,283,981, entitled “Method of Balancing Asymmetric Ultrasonic Surgical Blades,” issued Sep. 4, 2001, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 6,309,400, entitled “Curved Ultrasonic Blade having a Trapezoidal Cross Section,” issued Oct. 30, 2001, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 6,325,811, entitled “Blades with Functional Balance Asymmetries for use with Ultrasonic Surgical Instruments,” issued Dec. 4, 2001, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 6,423,082, entitled “Ultrasonic Surgical Blade with Improved Cutting and Coagulation Features,” issued Jul. 23, 2002, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 6,773,444, entitled “Blades with Functional Balance Asymmetries for Use with Ultrasonic Surgical Instruments,” issued Aug. 10, 2004, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 6,783,524, entitled “Robotic Surgical Tool with Ultrasound Cauterizing and Cutting Instrument,” issued Aug. 31, 2004, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 8,057,498, entitled “Ultrasonic Surgical Instrument Blades,” issued Nov. 15, 2011, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 8,461,744, entitled “Rotating Transducer Mount for Ultrasonic Surgical Instruments,” issued Jun. 11, 2013, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 8,591,536, entitled “Ultrasonic Surgical Instrument Blades,” issued Nov. 26, 2013, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 8,623,027, entitled “Ergonomic Surgical Instruments,” issued Jan. 7, 2014, the disclosure of which is incorporated by reference herein; and U.S. Pub. No. 2016/0022305, entitled “Ultrasonic Blade Overmold,” published Jan. 28, 2016, the disclosure of which is incorporated by reference herein.

Electrosurgical instruments utilize electrical energy for sealing tissue, and generally include a distally mounted end effector that can be configured for bipolar or monopolar operation. During bipolar operation, electrical current is provided through the tissue by active and return electrodes of the end effector. During monopolar operation, current is provided through the tissue by an active electrode of the end effector and a return electrode (e.g., a grounding pad) separately located on a patient's body. Heat generated by the current flowing through the tissue may form hemostatic seals within the tissue and/or between tissues, and thus may be particularly useful for sealing blood vessels, for example. The end effector of an electrosurgical device may also include a cutting member that is movable relative to the tissue and the electrodes to transect the tissue.

Electrical energy applied by an electrosurgical device can be transmitted to the instrument by a generator coupled with the instrument. The electrical energy may be in the form of radio frequency (“RF”) energy, which is a form of electrical energy generally in the frequency range of approximately 300 kilohertz (kHz) to 1 megahertz (MHz). In use, an electrosurgical device can transmit such energy through tissue, which causes ionic agitation, or friction, in effect resistive heating, thereby increasing the temperature of the tissue. Because a sharp boundary is created between the affected tissue and the surrounding tissue, surgeons can operate with a high level of precision and control, without sacrificing un-targeted adjacent tissue. The low operating temperatures of RF energy may be useful for removing, shrinking, or sculpting soft tissue while simultaneously sealing blood vessels. RF energy works particularly well on connective tissue, which is primarily comprised of collagen and shrinks when contacted by heat.

An example of an RF electrosurgical device is the ENSEAL® Tissue Sealing Device by Ethicon Endo-Surgery, Inc., of Cincinnati, Ohio. Further examples of electrosurgical devices and related concepts are disclosed in U.S. Pat. No. 6,500,176 entitled “Electrosurgical Systems and Techniques for Sealing Tissue,” issued Dec. 31, 2002, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,112,201 entitled “Electrosurgical Instrument and Method of Use,” issued Sep. 26, 2006, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,125,409, entitled “Electrosurgical Working End for Controlled Energy Delivery,” issued Oct. 24, 2006, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,169,146 entitled “Electrosurgical Probe and Method of Use,” issued Jan. 30, 2007, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,186,253, entitled “Electrosurgical Jaw Structure for Controlled Energy Delivery,” issued Mar. 6, 2007, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,189,233, entitled “Electrosurgical Instrument,” issued Mar. 13, 2007, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,220,951, entitled “Surgical Sealing Surfaces and Methods of Use,” issued May 22, 2007, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,309,849, entitled “Polymer Compositions Exhibiting a PTC Property and Methods of Fabrication,” issued Dec. 18, 2007, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,311,709, entitled “Electrosurgical Instrument and Method of Use,” issued Dec. 25, 2007, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,354,440, entitled “Electrosurgical Instrument and Method of Use,” issued Apr. 8, 2008, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,381,209, entitled “Electrosurgical Instrument,” issued Jun. 3, 2008, the disclosure of which is incorporated by reference herein.

Additional examples of electrosurgical devices and related concepts are disclosed in U.S. Pat. No. 8,939,974, entitled “Surgical Instrument Comprising First and Second Drive Systems Actuatable by a Common Trigger Mechanism,” issued Jan. 27, 2015, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 9,161,803, entitled “Motor Driven Electrosurgical Device with Mechanical and Electrical Feedback,” issued Oct. 20, 2015, the disclosure of which is incorporated by reference herein; U.S. Pub. No. 2012/0078243, entitled “Control Features for Articulating Surgical Device,” published Mar. 29, 2012, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 9,402,682, entitled “Articulation Joint Features for Articulating Surgical Device,” issued Aug. 2, 2016, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 9,089,327, entitled “Surgical Instrument with Multi-Phase Trigger Bias,” issued Jul. 28, 2015, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 9,545,253, entitled “Surgical Instrument with Contained Dual Helix Actuator Assembly,” issued Jan. 17, 2017, the disclosure of which is incorporated by reference herein; and U.S. Pat. No. 9,572,622, entitled “Bipolar Electrosurgical Features for Targeted Hemostasis,” issued Feb. 21, 2017, the disclosure of which is incorporated by reference herein.

Some instruments may provide ultrasonic and RF energy treatment capabilities through a single surgical device. Examples of such devices and related methods and concepts are disclosed in U.S. Pat. No. 8,663,220, entitled “Ultrasonic Surgical Instruments,” issued March 4, 2014, the disclosure of which is incorporated by reference herein; U.S. Pub. No. 2015/0141981, entitled “Ultrasonic Surgical Instrument with Electrosurgical Feature,” published May 21, 2015, the disclosure of which is incorporated by reference herein; and U.S. Pub. No. 2017/0000541, entitled “Surgical Instrument with User Adaptable Techniques,” published Jan. 5, 2017, the disclosure of which is incorporated by reference herein.

While various types of ultrasonic surgical instruments and electrosurgical instruments, including combination ultrasonic-electrosurgical devices, have been made and used, it is believed that no one prior to the inventor(s) has made or used the invention described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.

FIG. 1 depicts a schematic view of an exemplary ultrasonic surgical instrument including a shaft assembly and a handle assembly operatively connected to an ultrasonic generator;

FIG. 2A depicts a side view of an end effector of the ultrasonic surgical instrument of FIG. 1 showing the end effector in an open configuration for receiving tissue of a patient;

FIG. 2B depicts the side view of the end effector of FIG. 2A, but with the end effector in a closed configuration for clamping the tissue of the patient;

FIG. 3 depicts a flowchart of a method of rectifying production clamp force with the surgical system of FIG. 1;

FIG. 4 depicts a first version of determining an ultrasonic seal process based on the method of FIG. 3;

FIG. 5 depicts a second version of determining an ultrasonic seal process based on the method of FIG. 3; and

FIG. 6 depicts a graph of an exemplary variable ultrasonic seal process performed by the second version of determining the ultrasonic seal process in FIG. 5.

The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.

I. Exemplary Surgical System

FIG. 1 illustrates one example of a surgical system (10) including a surgical instrument (12) and a generator (14) coupled via a cable (16). Surgical instrument (12) has a proximally positioned handle assembly (18), which may also be referred to as a handpiece, a distally positioned end effector (20), a shaft assembly (22) extending therebetween, and an ultrasonic transducer (24). End effector (20) generally includes a clamp arm (26) pivotally connected relative to an ultrasonic blade (28) and configured to pivot from an open position of an open configuration to a closed position of a closed configuration as discussed below in greater detail. Ultrasonic blade (28) is acoustically coupled with ultrasonic transducer (24) via an acoustic waveguide (not shown) for providing ultrasonic energy to ultrasonic blade (28). In addition, end effector (20) further includes a plurality of RF electrodes (30) positioned therealong for contacting the tissue in either the open or closed position as desired by a clinician. Generator (14) operatively connects to ultrasonic blade (28) and RF electrodes (30) to respectively provide ultrasonic energy and RF energy to ultrasonic blade (28) and RF electrodes (30) to thereby cut and/or seal the tissue is use.

In some versions, clamp arm (26) has two or more electrodes (30). In some such versions, electrodes (30) of clamp arm are capable of applying bipolar RF energy to tissue. In some such versions, ultrasonic blade (28) remains electrically neutral, such that ultrasonic blade (28) is not part of the RF circuit. In some other versions, ultrasonic blade (28) forms part of the RF circuit, such that ultrasonic blade (28) cooperates with one or more electrodes (30) of clamp arm (26) to apply bipolar RF energy to tissue. By way of example only, some versions of clamp arm (26) may have just one electrode (30) that serves as an active pole for RF energy; while ultrasonic blade (28) provides a return pole for RF energy. Thus, the term “electrodes (30)” should be read to include versions where clamp arm (26) has only one single electrode.

It should be understood that terms such as “proximal” and “distal” are used herein with reference to surgical instrument (12). Thus, end effector (20) is distal with respect to the more proximal handle assembly (18). It will be further appreciated that for convenience and clarity, spatial terms such as “upper” and “lower” are used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute. Likewise, terms such as “instrument” and “device” as well as “limit” and “cap” may be used interchangeably.

-   -   A. Exemplary Generator

With reference to FIG. 1, generator (14) drives a combination surgical instrument (12) with both ultrasonic and RF energies. Generator (14) is shown separate from surgical instrument (12) in the present example, but, alternatively, generator (14) may be formed integrally with surgical instrument (12) to form a unitary surgical system. Generator (14) generally includes an input device (32) located on a front panel (34) of generator (14). Input device (32) may have any suitable device that generates signals suitable for programming the operation of generator (32). For example, in operation, the clinician may program or otherwise control operation of generator (32) using input device (32) (e.g., by one or more processors contained in the generator) to control the operation of generator (14) (e.g., operation of the ultrasonic generator drive circuit (not shown) and/or RF generator drive circuit (not shown)).

In various forms, input device (32) includes one or more buttons, switches, thumbwheels, keyboard, keypad, touch screen monitor, pointing device, remote connection to a general purpose or dedicated computer. In other forms, input device (32) may having a suitable user interface, such as one or more user interface screens displayed on a touch screen monitor. Accordingly, the clinician may selectively set or program various operating parameters of the generator, such as, current (I), voltage (V), frequency (f), and/or period (T) of a drive signal or signals generated by the ultrasonic and RF generator drive circuits (not shown). Specifically, in the present example, generator (32) is configured to deliver various power states to the surgical instrument (10) that include, but are not necessarily limited to, only ultrasonic energy, only RF energy, and a combination of ultrasonic and RF energies, which simultaneously powers ultrasonic blade (28) and RF electrodes (30). It will be appreciated that input device (32) may have any suitable device that generates signals suitable for programming the operation of generator (14) and should not be unnecessarily limited to input device (32) shown and described herein.

By way of example only, generator (14) may comprise a GEN04 or GEN11 sold by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio. In addition, or in the alternative, generator (14) may be constructed in accordance with at least some of the teachings of U.S. Pub. No. 2011/0087212, entitled “Surgical Generator for Ultrasonic and Electrosurgical Devices,” published Apr. 14, 2011, the disclosure of which is incorporated by reference herein.

-   -   B. Exemplary Surgical Instrument

Surgical instrument (10) of the present example shown in FIG. 1 includes a plurality of energy inputs, which are more particularly referred to herein as an upper button (36), lower button (38), and side button (40). By way of example, upper button (36) is configured to direct generator (14) to power ultrasonic transducer (24) with a maximum ultrasonic energy output, whereas lower button (38) is configured to direct generator (14) to power ultrasonic transducer (24) with a lower ultrasonic energy output. By way of further example, side button (40) is configured to direct generator (14) to power ultrasonic transducer (24) with a pulsed energy output, such as 5 continuous signals and 5 or 4 or 3 or 2 or 1 pulsed signals. In one or more examples, the specific drive signal configuration directed by energy inputs may be controlled and/or based upon EEPROM settings in generator (14) and/or user power level selection(s). By way of further example, surgical instrument (10) may include a two-button configuration for selectively directing ultrasonic and RF energies as described herein. Various examples of instruments having two-button input configurations are described in various patent references cited herein. In any case, it will be appreciated that the invention described herein is not intended to be unnecessarily limited to a particular input button, switch, etc. to the extent that any form of input may be so used.

Surgical instrument (12) further includes a first data circuit (42) and a second data circuit (44) in communication with generator (14). For example, first data circuit (42) indicates a burn-in frequency slope. Additionally or alternatively, any type of information may be communicated to second data circuit (42) for storage therein via a data circuit interface (e.g., using a logic device). Such information may comprise, for example, an updated number of operations in which surgical instrument (12) has been used and/or dates and/or times of its usage. In other examples, second data circuit (44) may transmit data acquired by one or more sensors (e.g., an instrument-based temperature sensor). In still other examples, second data circuit (44) may receive data from generator (14) and provide an indication to a clinician (e.g., an LED indication or other visible indication) based on the received data to and/or from surgical instrument (12). In the present example, second data circuit (44) stores information about the electrical and/or ultrasonic properties of an associated transducer (24) and/or end effector (20), which includes data measured and collected from ultrasonic blade (28) and/or RF electrodes (30).

To this end, various processes and techniques described herein are performed by a controller (46), which includes internal logic. In one example, controller (46) has at least one processor and/or other controller device in communication with generator (14), ultrasonic blade (28), RF electrodes (30), and other inputs and outputs described herein for monitoring and performing such processes and techniques. In one example, controller (46) has a processor configured to monitor user input provided via one or more inputs and capacitive touch sensors. Controller (46) may also include a touch screen controller to control and manage the acquisition of touch data from a capacitive touch screen.

With reference to FIGS. 1-2B, handle assembly (18) further includes a trigger (48) operatively connected to clamp arm (26). Trigger (48) and clamp arm (26) are generally biased toward the unactuated, open configuration. However, selectively manipulating trigger (48) proximally pivots clamp arm (26) toward ultrasonic blade (28) from the open position to the closed position. As used in the present example, clamp arm (26) and ultrasonic blade (28) may also be generally referred to respectively as upper and lower jaws of surgical instrument (12). In the open position, clamp arm (26) and ultrasonic blade (28) are configured to receive the tissue, whereas clamp arm (26) is configured to clamp tissue against ultrasonic blade (28) for grasping, sealing, and/or cutting the tissue.

Ultrasonic blade (28) ultrasonically vibrates to seal and/or cut the tissue, whereas RF electrodes (30) provide electrical power to the tissue. RF electrodes (30) of the present example are all electrically similar electrodes with ultrasonic blade (28) also electrically connected as a return electrode. As used therein, the term “electrode” may thus apply to both RF electrodes (30) and ultrasonic blade (28) with respect to the RF electrical circuit. Without tissue, the electrical circuit from RF electrodes (30) to ultrasonic blade (28) is open, whereas the electrical circuit is closed by the tissue between RF electrode (30) and ultrasonic blade (28) in use. RF electrodes (30) may be activated to apply RF energy alone or in combination with ultrasonic activation of ultrasonic blade (28). For example, activating only RF electrodes (30) to apply RF energy alone may be used for spot coagulating without concern for inadvertently cutting tissue with ultrasonically activated ultrasonic blade (28). However, the combination of ultrasonic energy and RF energy may be used for sealing and/or cutting tissue to achieve any combination of diagnostic or therapeutic effects, various examples of which will be described below in greater detail.

As noted above, generator (14) is a single output generator that can deliver power through a single port to provide both RF and ultrasonic energy such that these signals can be delivered separately or simultaneously to end effector (20) for cutting and/or sealing tissue. Such a single output port generator (14) has a single output transformer with multiple taps to provide power, either for RF or for ultrasonic energy, to end effector (20) depending on the particular treatment being performed on the tissue. For example, generator (14) may deliver energy with higher voltage and lower current to drive ultrasonic transducer (24), with lower voltage and higher current as required to drive RF electrodes (30) for sealing tissue, or with a coagulation waveform for spot coagulation using either monopolar or bipolar electrosurgical electrodes. The output waveform from generator (14) can be steered, switched, or filtered to provide the desired frequency to end effector (20) of surgical instrument (12).

II. Production Clamp Force Rectification

Variations in clamp force of tissue between lower jaw, such as ultrasonic blade (28), and upper jaw, such as clamp arm (26), tend to affect sealing and transection of the tissue in generally any method of operating surgical system (10) of FIG. 1, such as those described herein, particularly with respect to ultrasonic energy. Thus, manufacturing tolerances associated with assembly of surgical instrument (12), to at least some extent, affect a production clamp force for each respective surgical instrument (12) that similarly affect sealing and transection. As used herein, the term “production clamp force” refers to a particular clamp force generated between clamp arm (26) and ultrasonic blade (28) after an initial assembly of a particular surgical system (10) during manufacturing. Each respective surgical instrument (12) may thus have a relatively unique production clamp force that varies, if only slightly, from a preferred, predetermined clamp force. While such effects may be trivial in some tissue treatments, rectification of the production clamp force toward the preferred, predetermined clamp force for each surgical instrument (12) provides greater consistency from a manufacturing process for sealing and/or transecting tissue in use.

With respect to FIG. 3, a method (1010) of manufacturing surgical instrument (12) of FIG. 1 includes a step (1012) of starting assembly of ultrasonic instrument (12). Following step (1012), end effector (20) is assembled with ultrasonic blade (28) and clamp arm (26) in a step (1014). Once end effector (20) is assembled, ultrasonic blade (28) and clamp arm (26) are clamped together to the closed position in a step (1016), and the manufacturer then measures the production clamp force for that particular end effector (20) without a foreign substance, such as tissue, between ultrasonic blade (28) and clamp arm (26) in a step (1018). A memory of surgical instrument (12), such as the EEPROM, receives an ultrasonic seal process configured to rectify the production clamp force to seal the tissue while inhibiting transection of the tissue in a step (1020). Once surgical instrument (12) is sufficiently assembled in a step (1022) following step (1020), surgical instrument (12) may then be used by the clinician for applying RF and/or ultrasonic energies to the tissue of the patient.

Memory may be configured during manufacturing method (1010) to either perform the rectified ultrasonic seal process on tissue based on the production clamp force determined during the manufacturing method or include the predetermined clamp force stored therein, which is determined in real-time during use on the tissue. The present example determines the production clamp force in real-time during use as described below, but the invention is not intended to be unnecessarily limited to the real-time determination.

To this end, a first process (1040) of sealing tissue with an ultrasonic seal process is shown in FIG. 4 with respect to surgical system (10) of FIG. 1. In a step (1042), the tissue is clamped between ultrasonic blade (28) and clamp arm (26) in a closed position with an applied clamp force greater than the production clamp force, which was measured in step (1018). Based on the production clamp force stored in memory, controller (46) accesses the stored production clamp force and determine whether the production clamp force is a low production clamp force, a lower intermediate production clamp force, a higher intermediate clamp force, or a high production clamp force. In other words, controller (46) effectively classifies the production clamp force. In one example, the low production clamp is between approximately 3.5 lbf and approximately 4.0 lbf, the lower intermediate production clamp force is between approximately 4.0 lbf and approximately 4.5 lbf, the higher intermediate clamp force is between approximately 4.5 lbf and approximately 5.0 lbf, and the high production clamp force is between approximately 5.0 lbf and approximately 5.5 lbf.

With the clamp force classified, controller (46) then directs RF and ultrasonic energies to activate such that the ultrasonic energy is delivered to the tissue with a respective ultrasonic seal process classification for each production clamp force in a step (1046), a step (1048), a step (1050), and a step (1052). First, ultrasonic energy is activated in step (1046) with a high energy ultrasonic seal process based on lower production clamp force. Second, ultrasonic energy is activated in step (1048) with a higher intermediate energy ultrasonic seal process based on lower intermediate production clamp force. Third, ultrasonic energy is activated in step (1050) with a lower intermediate energy ultrasonic seal process based on higher intermediate production clamp force. Fourth, ultrasonic energy is activated in step (1052) with a low energy ultrasonic seal process based on high production clamp force.

In any case, the tissue is sealed in a step (1054) such that transection of the tissue inhibited by the ultrasonic energy seal process for the respective determined production clamp force. Once the tissue is sealed, controller (46) directs the RF energy and the ultrasonic energy to terminate in a step (1056). While the above referenced terms “low,” “lower intermediate,” “higher intermediate,” and “high” are used to provide relative references to both production clamp forces and ultrasonic seal processes, these terms are not intended to unnecessarily limit the invention described herein.

FIG. 5 illustrates a second process (1080) of sealing tissue with an ultrasonic seal process with respect to surgical system (10) of FIG. 1. The clinician first clamps the tissue as described above in step (1042), but, rather than determine the particular production clamp force classification and associated ultrasonic seal energy processes, the stored production clamp force (1082) is input into an ultrasonic seal process transfer function (1084) in a step (1086). Thereby, step (1086) determines a variable ultrasonic seal process based on the production clamp force (1082) and the ultrasonic seal process transfer function (1084). In a step (1088) controller (46) activates the RF energy and the ultrasonic energy such that the ultrasonic energy applies the variable ultrasonic seal process in use. One exemplary variable ultrasonic seal process is shown in FIG. 6 as linearly decreasing function. However, it will be appreciated that other functions may be so used in accordance with the invention discussed herein. In any case, with the RF and ultrasonic energies activated as in step (1088) of FIG. 5, the tissue is sealed while inhibiting transection of the tissue in a step (1090). Controller (46) finally terminates the RF and ultrasonic energy in a step (1092). While the above processes (1040, 1080) of method (1010) specifically adjust ultrasonic energy to accommodate predetermined clamp forces for inhibiting tissue transection, it will be appreciated that RF energy may also be adjusted in other examples. The invention is thus not intended to be limited to only ultrasonic energy adjustment.

III. Exemplary Combinations

The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to restrict the coverage of any claims that may be presented at any time in this application or in subsequent filings of this application. No disclaimer is intended. The following examples are being provided for nothing more than merely illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in numerous other ways. It is also contemplated that some variations may omit certain features referred to in the below examples. Therefore, none of the aspects or features referred to below should be deemed critical unless otherwise explicitly indicated as such at a later date by the inventors or by a successor in interest to the inventors. If any claims are presented in this application or in subsequent filings related to this application that include additional features beyond those referred to below, those additional features shall not be presumed to have been added for any reason relating to patentability.

Example 1

A method of sealing a tissue with a surgical instrument including an ultrasonic blade and an RF electrode respectively configured to deliver an ultrasonic energy and an RF energy to the tissue, wherein the surgical instrument has a controller with a production clamp force and an ultrasonic seal process stored thereon, the method comprising: (a) determining the ultrasonic seal process with the controller based on the production clamp force between an upper jaw and a lower jaw of an end effector; (b) activating at least one of ultrasonic energy or RF energy respectively to the ultrasonic blade or the RF electrode according to the determined ultrasonic seal process; and (c) sealing the tissue with the at least one of the ultrasonic or RF energies.

Example 2

The method of Example 1, further comprising accessing the production clamp force and the ultrasonic seal process stored on the controller.

Example 3

The method of any one or more of Examples 1 through 2, further comprising: (a) determining a relative size of the production clamp force from a plurality of predetermined production clamp force sizes; and (b) adjusting activation of at least one of the RF energy or the ultrasonic energy based on the determined relative size of the production clamp force.

Example 4

The method of Example 3, wherein the ultrasonic seal process includes a plurality of predetermined ultrasonic seal processes, and wherein the method further comprises selecting one of the plurality of predetermined ultrasonic seal processes based on the determined relative size of the production clamp force.

Example 5

The method of Example 4, wherein the plurality of predetermined production clamp force sizes includes a low production clamp force and a high production clamp force, wherein the plurality of predetermined ultrasonic seal processes includes a high ultrasonic seal process and a low ultrasonic seal process, and wherein the high ultrasonic seal process is configured to activate a relatively high amount of energy and the low ultrasonic seal process is configured to activate a relatively low amount of energy.

Example 6

The method of Example 5, wherein the determined relative size of the production clamp force is a low production clamp force, and wherein activating at least one of ultrasonic energy or RF energy further includes activating at least one of ultrasonic energy or RF energy respectively to the ultrasonic blade or the RF electrode according to the high ultrasonic seal process.

Example 7

The method of Example 6, wherein activating at least one of ultrasonic energy or RF energy further includes activating the ultrasonic energy and the RF energy with the high ultrasonic seal process.

Example 8

The method of Example 5, wherein the determined relative size of the production clamp force is a high production clamp force, and wherein activating at least one of ultrasonic energy or RF energy further includes activating at least one of ultrasonic energy or RF energy respectively to the ultrasonic blade or the RF electrode according to the low ultrasonic seal process.

Example 9

The method of Example 8, wherein activating at least one of ultrasonic energy or RF energy further includes activating the ultrasonic energy and the RF energy with the low ultrasonic seal process.

Example 10

The method of any one or more of Examples 5 through 9, wherein the low production clamp force is less than 4.5 lbf, and wherein the high production clamp force is greater than 4.5 lbf.

Example 11

The method of Example 2, wherein the ultrasonic seal process is an ultrasonic seal process transfer function, and wherein the method further comprises determining a variable ultrasonic seal process based on the production clamp force.

Example 12

The method of Example 11, wherein activating at least one of ultrasonic energy or RF energy further includes activating the ultrasonic energy and the RF energy with the variable ultrasonic seal process.

Example 13

The method of any one or more of Examples 1 through 12, further comprising measuring the production clamp force between the lower jaw and the upper jaw.

Example 14

The method of Example 3, further comprising configuring the controller with a memory including the production clamp force and the ultrasonic seal process stored thereon.

Example 15

The method of Example 14, wherein the ultrasonic seal process stored thereon includes at least one of a plurality of predetermined ultrasonic seal processes or a variable ultrasonic seal process.

Example 16

A method of manufacturing a surgical instrument including an end effector with an upper jaw and a lower jaw, wherein the surgical instrument has a controller, the method comprising: (a) measuring a production clamp force between the upper and lower jaw; and (b) configuring a memory of controller with an ultrasonic seal process based on the measured production clamp force.

Example 17

The method of Example 16, further comprising assembling the upper jaw relative to the lower jaw to form the end effector.

Example 18

The method of any one or more of Examples 16 through 17, wherein the ultrasonic seal process stored thereon includes at least one of a plurality of predetermined ultrasonic seal processes or a variable ultrasonic seal process.

Example 19

An ultrasonic surgical instrument, comprising: (a) an end effector configured to actuate from a first configuration to a second configuration, including: (i) an ultrasonic blade configured to selectively apply ultrasonic energy to a tissue, (ii) a jaw movably positioned relative to the ultrasonic blade and configured to move between an open position and a closed position, wherein the jaw and ultrasonic blade in the open position are configured to receive the tissue, and wherein the jaw and ultrasonic blade in the closed position are configured to clamp together with a production clamp force, and (iii) an RF electrode configured to selectively apply RF energy to the tissue clamped within the end effector, wherein the RF electrode is further configured to measure a tissue impedance of a tissue clamped within the end effector; (b) a shaft assembly projecting proximally from the end effector; (c) a body projecting proximally from the shaft assembly, wherein the body includes an energy input operatively connected to the ultrasonic blade; and (d) a controller operatively connected to the ultrasonic blade and the RF electrode and having a memory including an ultrasonic seal process based on the production clamp force stored thereon, wherein the controller is configured to drive at least one of the ultrasonic blade or the RF electrode according to the ultrasonic seal process.

Example 20

The ultrasonic surgical instrument of Example 19, wherein the ultrasonic seal process stored thereon includes at least one of a plurality of predetermined ultrasonic seal processes or a variable ultrasonic seal process.

IV. Miscellaneous

It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. that are described herein. The above-described teachings, expressions, embodiments, examples, etc. should therefore not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined will be readily apparent to those of ordinary skill in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of any claims.

Any one or more of the teaching, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the teachings, expressions, embodiments, examples, etc. described in U.S. Pat. App. No. [Atty. Ref. END8146USNP], entitled “Combination Ultrasonic and Electrosurgical Instrument with Clamp Arm Position Input and Method for Identifying Tissue State,” filed on even date herewith; U.S. Pat. App. No. [Atty. Ref. END8146USNP1], entitled “Combination Ultrasonic and Electrosurgical Instrument with Adjustable Energy Modalities and Method for Sealing Tissue and Inhibiting Tissue Resection,” filed on even date herewith; U.S. Pat. App. No. [Atty. Ref. END8146USNP3], entitled “Combination Ultrasonic and El ectrosurgical Instrument with Adjustable Energy Modalities and Method for Limiting Blade Temperature,” filed on even date herewith; U.S. Pat. App. No. [Atty. Ref. END8146USNP4], entitled “Combination Ultrasonic and Electrosurgical Instrument and Method for Sealing Tissue with Various Termination Parameters,” filed on even date herewith; and/or U.S. Pat. App. No. [Atty. Ref. END8146USNP5], entitled “Combination Ultrasonic and Electrosurgical Instrument and Method for Sealing Tissue in Successive Phases,” filed on even date herewith. The disclosure of each of these applications is incorporated by reference herein.

Further, any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the teachings, expressions, embodiments, examples, etc. described in U.S. Pat. App. No. [Atty. Ref. END8245USNP], entitled “Combination Ultrasonic and Electrosurgical Instrument Having Electrical Circuits With Shared Return Path,” filed on even date herewith; U.S. Pat. App. No. [Atty. Ref. END8245USNP1], entitled “Combination Ultrasonic and Electrosurgical Instrument Having Slip Ring Electrical Contact Assembly,” filed on even date herewith; U.S. Pat. App. No. [Atty. Ref. END8245USNP2], entitled “Combination Ultrasonic and Electrosurgical Instrument Having Electrically Insulating Features,” filed on even date herewith; U.S. Pat. App. No. [Atty. Ref. END8245USNP3], entitled “Combination Ultrasonic and Electrosurgical Instrument Having Curved Ultrasonic Blade,” filed on even date herewith; U.S. Pat. App. No. [Atty. Ref. END8245USNP4], entitled “Combination Ultrasonic and Electrosurgical Instrument Having Clamp Arm Electrode,” filed on even date herewith; U.S. Pat. App. No. [Atty. Ref. END8245USNP5], entitled “Combination Ultrasonic and Electrosurgical Instrument Having Ultrasonic Waveguide With Distal Overmold Member,” filed on even date herewith; U.S. Pat. App. No. [Atty. Ref. END8245USNP6], entitled “Combination Ultrasonic and Electrosurgical System Having Generator Filter Circuitry,” filed on even date herewith; and/or U.S. Pat. App. No. [Atty. Ref. END8245USNP7], entitled “Combination Ultrasonic and Electrosurgical System Having EEPROM and ASIC Components,” filed on even date herewith. The disclosure of each of these applications is incorporated by reference herein.

It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

Versions of the devices described above may have application in conventional medical treatments and procedures conducted by a medical professional, as well as application in robotic-assisted medical treatments and procedures. By way of example only, various teachings herein may be readily incorporated into a robotic surgical system such as the DAVINCI™ system by Intuitive Surgical, Inc., of Sunnyvale, Calif. Similarly, those of ordinary skill in the art will recognize that various teachings herein may be readily combined with various teachings of any of the following: U.S. Pat. No. 5,792,135, entitled “Articulated Surgical Instrument For Performing Minimally Invasive Surgery With Enhanced Dexterity and Sensitivity,” issued Aug. 11, 1998, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 5,817,084, entitled “Remote Center Positioning Device with Flexible Drive,” issued Oct. 6, 1998, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 5,878,193, entitled “Automated Endoscope System for Optimal Positioning,” issued Mar. 2, 1999, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 6,231,565, entitled “Robotic Arm DLUS for Performing Surgical Tasks,” issued May 15, 2001, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 6,783,524, entitled “Robotic Surgical Tool with Ultrasound Cauterizing and Cutting Instrument,” issued Aug. 31, 2004, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 6,364,888, entitled “Alignment of Master and Slave in a Minimally Invasive Surgical Apparatus,” issued Apr. 2, 2002, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,524,320, entitled “Mechanical Actuator Interface System for Robotic Surgical Tools,” issued Apr. 28, 2009, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,691,098, entitled “Platform Link Wrist Mechanism,” issued Apr. 6, 2010, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,806,891, entitled “Repositioning and Reorientation of Master/Slave Relationship in Minimally Invasive Telesurgery,” issued Oct. 5, 2010, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 8,844,789, entitled “Automated End Effector Component Reloading System for Use with a Robotic System,” issued Sept. 30, 2014, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 8,820,605, entitled “Robotically-Controlled Surgical Instruments,” issued Sept. 2, 2014, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 8,616,431, entitled “Shiftable Drive Interface for Robotically-Controlled Surgical Tool,” issued Dec. 31, 2013, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 8,573,461, entitled “Surgical Stapling Instruments with Cam-Driven Staple Deployment Arrangements,” issued Nov. 5, 2013, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 8,602,288, entitled “Robotically-Controlled Motorized Surgical End Effector System with Rotary Actuated Closure Systems Having Variable Actuation Speeds,” issued Dec. 10, 2013, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 9,301,759, entitled “Robotically-Controlled Surgical Instrument with Selectively Articulatable End Effector,” issued Apr. 5, 2016, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 8,783,541, entitled “Robotically-Controlled Surgical End Effector System,” issued Jul. 22, 2014, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 8,479,969, entitled “Drive Interface for Operably Coupling a Manipulatable Surgical Tool to a Robot,” issued July 9, 2013; U.S. Pat. Pub. No. 8,800,838, entitled “Robotically-Controlled Cable-Based Surgical End Effectors,” issued Aug. 12, 2014, the disclosure of which is incorporated by reference herein; and/or U.S. Pat. No. 8,573,465, entitled “Robotically-Controlled Surgical End Effector System with Rotary Actuated Closure Systems,” issued Nov. 5, 2013, the disclosure of which is incorporated by reference herein.

Versions of the devices described above may be designed to be disposed of after a single use, or they can be designed to be used multiple times. Versions may, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, some versions of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, some versions of the device may be reassembled for subsequent use either at a reconditioning facility, or by a clinician immediately prior to a procedure. Those skilled in the art will appreciate that reconditioning of a device may utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

By way of example only, versions described herein may be sterilized before and/or after a procedure. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and device may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation may kill bacteria on the device and in the container. The sterilized device may then be stored in the sterile container for later use. A device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

Having shown and described various embodiments of the present invention, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, embodiments, geometrics, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present invention is understood not to be limited to the details of structure and operation shown and described in the specification and drawings. 

I/We claim:
 1. A method of sealing a tissue with a surgical instrument including an ultrasonic blade and an RF electrode respectively configured to deliver an ultrasonic energy and an RF energy to the tissue, wherein the surgical instrument has a controller with a production clamp force and an ultrasonic seal process stored thereon, the method comprising: (a) determining the ultrasonic seal process with the controller based on the production clamp force between an upper jaw and a lower jaw of an end effector; (b) activating at least one of ultrasonic energy or RF energy respectively to the ultrasonic blade or the RF electrode according to the determined ultrasonic seal process; and (c) sealing the tissue with the at least one of the ultrasonic or RF energies.
 2. The method of claim 1, further comprising accessing the production clamp force and the ultrasonic seal process stored on the controller.
 3. The method of claim 2, further comprising: (a) determining a relative size of the production clamp force from a plurality of predetermined production clamp force sizes; and (b) adjusting activation of at least one of the RF energy or the ultrasonic energy based on the determined relative size of the production clamp force.
 4. The method of claim 3, wherein the ultrasonic seal process includes a plurality of predetermined ultrasonic seal processes, and wherein the method further comprises selecting one of the plurality of predetermined ultrasonic seal processes based on the determined relative size of the production clamp force.
 5. The method of claim 4, wherein the plurality of predetermined production clamp force sizes includes a low production clamp force and a high production clamp force, wherein the plurality of predetermined ultrasonic seal processes includes a high ultrasonic seal process and a low ultrasonic seal process, and wherein the high ultrasonic seal process is configured to activate a relatively high amount of energy and the low ultrasonic seal process is configured to activate a relatively low amount of energy.
 6. The method of claim 5, wherein the determined relative size of the production clamp force is a low production clamp force, and wherein activating at least one of ultrasonic energy or RF energy further includes activating at least one of ultrasonic energy or RF energy respectively to the ultrasonic blade or the RF electrode according to the high ultrasonic seal process.
 7. The method of claim 6, wherein activating at least one of ultrasonic energy or RF energy further includes activating the ultrasonic energy and the RF energy with the high ultrasonic seal process.
 8. The method of claim 5, wherein the determined relative size of the production clamp force is a high production clamp force, and wherein activating at least one of ultrasonic energy or RF energy further includes activating at least one of ultrasonic energy or RF energy respectively to the ultrasonic blade or the RF electrode according to the low ultrasonic seal process.
 9. The method of claim 8, wherein activating at least one of ultrasonic energy or RF energy further includes activating the ultrasonic energy and the RF energy with the low ultrasonic seal process.
 10. The method of claim 5, wherein the low production clamp force is less than 4.5 lbf, and wherein the high production clamp force is greater than 4.5 lbf.
 11. The method of claim 2, wherein the ultrasonic seal process is an ultrasonic seal process transfer function, and wherein the method further comprises determining a variable ultrasonic seal process based on the production clamp force.
 12. The method of claim 11, wherein activating at least one of ultrasonic energy or RF energy further includes activating the ultrasonic energy and the RF energy with the variable ultrasonic seal process.
 13. The method of claim 1, further comprising measuring the production clamp force between the lower jaw and the upper jaw.
 14. The method of claim 3, further comprising configuring the controller with a memory including the production clamp force and the ultrasonic seal process stored thereon.
 15. The method of claim 14, wherein the ultrasonic seal process stored thereon includes at least one of a plurality of predetermined ultrasonic seal processes or a variable ultrasonic seal process.
 16. A method of manufacturing a surgical instrument including an end effector with an upper jaw and a lower jaw, wherein the surgical instrument has a controller, the method comprising: (a) measuring a production clamp force between the upper and lower jaw; and (b) configuring a memory of controller with an ultrasonic seal process based on the measured production clamp force.
 17. The method of claim 16, further comprising assembling the upper jaw relative to the lower jaw to form the end effector.
 18. The method of claim 16, wherein the ultrasonic seal process stored thereon includes at least one of a plurality of predetermined ultrasonic seal processes or a variable ultrasonic seal process.
 19. An ultrasonic surgical instrument, comprising: (a) an end effector configured to actuate from a first configuration to a second configuration, including: (i) an ultrasonic blade configured to selectively apply ultrasonic energy to a tissue, (ii) a jaw movably positioned relative to the ultrasonic blade and configured to move between an open position and a closed position, wherein the jaw and ultrasonic blade in the open position are configured to receive the tissue, and wherein the jaw and ultrasonic blade in the closed position are configured to clamp together with a production clamp force, and (iii) an RF electrode configured to selectively apply RF energy to the tissue clamped within the end effector, wherein the RF electrode is further configured to measure a tissue impedance of a tissue clamped within the end effector; (b) a shaft assembly projecting proximally from the end effector; (c) a body projecting proximally from the shaft assembly, wherein the body includes an energy input operatively connected to the ultrasonic blade; and (d) a controller operatively connected to the ultrasonic blade and the RF electrode and having a memory including an ultrasonic seal process based on the production clamp force stored thereon, wherein the controller is configured to drive at least one of the ultrasonic blade or the RF electrode according to the ultrasonic seal process.
 20. The ultrasonic surgical instrument of claim 19, wherein the ultrasonic seal process stored thereon includes at least one of a plurality of predetermined ultrasonic seal processes or a variable ultrasonic seal process. 